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FDA 510(k)

Distal Centralizers

K-Number: K193546 · 2020-09-25

ApplicantBiomet, Inc.
Decision Date2020-09-25
Product CodeJDG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Distal Centralizers is a medical device manufactured by Biomet, Inc.. It received FDA 510(k) clearance on 2020-09-25 under approval number K193546. The device is classified under product code JDG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Distal Centralizers?

Distal Centralizers is a medical device that received FDA 510(k) clearance on 2020-09-25. It is manufactured by Biomet, Inc.. The 510(k) number is K193546.

When was Distal Centralizers approved by the FDA?

Distal Centralizers received FDA 510(k) clearance on 2020-09-25, under approval number K193546.

What company makes Distal Centralizers?

Distal Centralizers is manufactured by Biomet, Inc..

What is the FDA product code for Distal Centralizers?

The FDA product code for Distal Centralizers is JDG.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.